Effects of Peripheral Magnetic Stimulation on Cortical Excitability in Healthy Individuals

NCT ID: NCT07025759

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-10-31

Brief Summary

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This study investigates the immediate effects of different parameters (frequency, intensity, and pulse number) of peripheral magnetic stimulation (rPMS) on cortical excitability in healthy individuals. Using a randomized, double-blind crossover design, the research aims to identify optimal stimulation protocols for modulating neural activity. Outcomes include measurements of motor-evoked potentials (MEPs), intracortical inhibition (ICI), and facilitation (ICF). Findings may enhance non-invasive therapeutic strategies for neurological disorders.

Detailed Description

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This clinical trial is a crossover trial comparing 9 single-session rPMS protocols over the extensor carpi radialis muscle, testing three frequencies (1Hz, 10Hz, 25Hz), intensities (90%, 100%, 110% of resting motor threshold) across sequential phases.

Participants: Healthy adults (18-40 years) undergo pre-/post-intervention assessments: cortical (MEPs, ICI/ICF) excitability.

Design: Crossover, double-blind.

Analysis: ANOVA or Friedman tests (SPSS v20.0; α=0.05).

Significance: Clarifies parameter-specific neuromodulatory effects, guiding future rehabilitation protocols for neurological conditions.

Ethics: Approved by Federal University of Pernambuco's ethics committee (Resolution 466/12). Data stored securely for 5 years.

Conditions

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Healthy Individuals

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Peripheral magnetic stimulation (90% + 1 Hz)

Group Type ACTIVE_COMPARATOR

Peripheral magnetic stimulation (90% of RMT + 1 Hz)

Intervention Type DEVICE

Low-frequency stimulation (1 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses.

Peripheral magnetic stimulation (100% + 25 Hz)

Group Type ACTIVE_COMPARATOR

Peripheral magnetic stimulation (100% of RMT + 25 Hz)

Intervention Type DEVICE

High-frequency (25 Hz), at resting motor threshold intensity (100%) protocol delivering 2400 pulses.

Peripheral magnetic stimulation (90% + 25 Hz)

Group Type ACTIVE_COMPARATOR

Peripheral magnetic stimulation (90% of RMT + 25 Hz)

Intervention Type DEVICE

High-frequency stimulation (25 Hz) at 90% of resting muscle threshold intensity, with 2400 pulses.

Peripheral magnetic stimulation (100% + 1 Hz)

Group Type ACTIVE_COMPARATOR

Peripheral magnetic stimulation (100% of RMT + 1 Hz)

Intervention Type DEVICE

Low-frequency (1 Hz), at resting motor threshold intensity (100%) protocol delivering 2400 pulses.

Peripheral magnetic stimulation (100% + 10 Hz)

Group Type ACTIVE_COMPARATOR

Peripheral magnetic stimulation (100% of RMT + 10 Hz)

Intervention Type DEVICE

High-frequency (10 Hz), at resting motor threshold intensity (100%) protocol delivering 2400 pulses.

Peripheral magnetic stimulation (110% + 1 Hz)

Group Type ACTIVE_COMPARATOR

Peripheral magnetic stimulation (110% of RMT + 1Hz)

Intervention Type DEVICE

Low-frequency (1 Hz), above resting motor threshold intensity (110%) protocol delivering 2400 pulses.

Peripheral magnetic stimulation (110% + 10 Hz)

Group Type ACTIVE_COMPARATOR

Peripheral magnetic stimulation (110% of RMT + 10Hz)

Intervention Type DEVICE

High-frequency (10 Hz), above resting motor threshold intensity (110%) protocol delivering 2400 pulses.

Peripheral magnetic stimulation (110% + 25 Hz)

Group Type ACTIVE_COMPARATOR

Peripheral magnetic stimulation (110% of RMT + 25Hz)

Intervention Type DEVICE

High-frequency (25 Hz), above resting motor threshold intensity (110%) protocol delivering 2400 pulses.

Peripheral magnetic stimulation (90% + 10 Hz)

Group Type ACTIVE_COMPARATOR

Peripheral magnetic stimulation (90% of RMT + 10 Hz)

Intervention Type DEVICE

High-frequency stimulation (10 Hz) at 90% of resting motor threshold intensity, totaling 2400 pulses.

Interventions

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Peripheral magnetic stimulation (90% of RMT + 1 Hz)

Low-frequency stimulation (1 Hz) at 90% of resting motor threshold intensity, delivering a total of 2400 pulses.

Intervention Type DEVICE

Peripheral magnetic stimulation (90% of RMT + 10 Hz)

High-frequency stimulation (10 Hz) at 90% of resting motor threshold intensity, totaling 2400 pulses.

Intervention Type DEVICE

Peripheral magnetic stimulation (90% of RMT + 25 Hz)

High-frequency stimulation (25 Hz) at 90% of resting muscle threshold intensity, with 2400 pulses.

Intervention Type DEVICE

Peripheral magnetic stimulation (100% of RMT + 1 Hz)

Low-frequency (1 Hz), at resting motor threshold intensity (100%) protocol delivering 2400 pulses.

Intervention Type DEVICE

Peripheral magnetic stimulation (100% of RMT + 10 Hz)

High-frequency (10 Hz), at resting motor threshold intensity (100%) protocol delivering 2400 pulses.

Intervention Type DEVICE

Peripheral magnetic stimulation (100% of RMT + 25 Hz)

High-frequency (25 Hz), at resting motor threshold intensity (100%) protocol delivering 2400 pulses.

Intervention Type DEVICE

Peripheral magnetic stimulation (110% of RMT + 1Hz)

Low-frequency (1 Hz), above resting motor threshold intensity (110%) protocol delivering 2400 pulses.

Intervention Type DEVICE

Peripheral magnetic stimulation (110% of RMT + 10Hz)

High-frequency (10 Hz), above resting motor threshold intensity (110%) protocol delivering 2400 pulses.

Intervention Type DEVICE

Peripheral magnetic stimulation (110% of RMT + 25Hz)

High-frequency (25 Hz), above resting motor threshold intensity (110%) protocol delivering 2400 pulses.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Inclusion criteria: Healthy adults aged 18-40 years, both sexes, right-handed (confirmed via Edinburgh Handedness Inventory), and for females, consistent use of contraceptive medication to mitigate hormonal influences on nervous system excitability.

Exclusion criteria: Pregnancy; history of seizures or epilepsy; metallic implants in the head, spine, face, or heart; diagnosed neurological or musculoskeletal conditions interfering with assessments or interventions; or use of substances altering nervous system excitability.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Kátia Monte-Silva

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidade Federal de Pernambuco

Recife, Pernambuco, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Kátia Monte-Silva

Role: CONTACT

+55 81 21267579

Facility Contacts

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Monte-Silva

Role: primary

+55 81 21267579

Other Identifiers

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Parameters_pMS

Identifier Type: -

Identifier Source: org_study_id

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